CTRI/2022/05/042759
Recruiting
Phase 4
Comparison of efficacy & safety of two frontline induction regimens in newly diagnosed multiple myeloma: A randomized, assessor-blinded pilot study - CARBO
ConditionsHealth Condition 1: C00-D49- Neoplasms
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Sponsor
- AIIMS Rishikesh
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients of newly diagnosed symptomatic multiple myeloma (as per IMWG38 diagnostic criteria), of age \>\= 18 years \& any gender, who are willing to participate in the study.
- •Patients with measurable disease as defined by \>\= 1 of the following criteria, obtained within 1 month of randomization:
- •o \> 1 g/dL monoclonal protein on serum protein electrophoresis (SPEP)
- •o \> 200 mg/24 hours of monoclonal protein on a 24 hour urine protein electrophoresis (UPEP)
- •oSerum involved free light chain (SFLC) \>\= 100 mg/L and abnormal serum immunoglobulin kappa to lambda free light chain ratio ( \< 0\.26 or \> 1\.65\)
- •Life expectancy \>\= 6 months.
- •Written informed consent.
- •Patients with a history of prior malignancy who have been treated with curative intent and do not require active therapy.
- •If there is no residual toxicity related to prior radiation given to symptomatic lesions, patient can be included in the study.
Exclusion Criteria
- •Pregnant women
- •Nursing women
- •Patients who have received more than one cycle (4 weeks or less) and 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic multiple myeloma.
- •Patients with uncontrolled hypertension or diabetes, New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF), unstable angina, myocardial infarction within previous 6 months, Grade 3 conduction abnormalities unless patient has a pacemaker, history of torsade de pointes, QTc prolongation ( \>450 msec), left ventricular ejection fraction \<40%, uncontrolled arrhythmia, sick sinus syndrome, or any medical condition that would compromise with compliance with protocol and therapy.
- •Patients with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM).
- •Patients with peripheral neuropathy ( grade 3\-4 or lower grade with pain) by Common Terminology Criteria for Adverse Events (CTCAE) 5\.0\.37
- •Patients having severe, uncontrolled illness.
- •Plasma cell leukemia ( absolute plasma cell count \> 2 x 109/L or 20 percent of peripheral white blood cells).
Outcomes
Primary Outcomes
Not specified
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